Senior Specialist, Clinical Patient Safety and Pharmacovigilance Operations

This is a hybrid role typically requiring on-site presence at least 3 days per week in Redwood City, CA. The role supports Patient Safety and Pharmacovigilance (PSPV) Safety Operations activities in clinical trial settings.

Responsibilities:

• Support the oversight of safety vendors to ensure high quality delivery in the collection, processing, reporting, and reconciliation of adverse event reports in compliance with global regulatory reporting requirements, including but not limited to:
  • Performing quality review of individual case safety reports (ICSRs)
  • Monitoring case volume and workflow timelines
  • Support review of expedited and aggregate report submissions, including quality review and archival of records
• Perform safety operations study start-up activities, e.g., developing safety management plans, study forms, completion guidelines, safety related training
• Perform ongoing and end of study safety operations clinical trial activities, e.g., SAE reconciliation, Trial Master File maintenance, assigning study-specific training to PSPV personnel and vendors
• Managing PSPV mailboxes, including supporting intake reconciliation
• Develop and maintain departmental SOPs, work instructions, and training materials
• Delivery training to internal teams, Investigator sites and/or vendors
• Support and participate in audits and inspections, including preparation activities
• Assist with additional PSPV projects as requested

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet patient and corporate needs
• Knowledge of Argus (or similar safety applications), electronic data capture systems, and MedDRA and WHO Drug coding dictionaries
• Excellent communication skills (verbal and written)
• Ability to collaborate with cross-functional teams and manage multiple projects in a fast-paced environment
• Able to travel for up to 10% of time
• Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections)

Preferred Education and Experience:

• Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD is preferred
• Minimum of 3 years Drug Safety/PV experience in a global environment
• Experience in clinical trial safety operations is preferred
• Working knowledge of FDA, EU, and ICH guidelines for safety reporting
• Able to travel for up to 10% of time
• Must be willing and have flexibility to come to office more than 3 days week to meet business needs (e.g., regulatory inspections)

The pay range that the Company reasonably expects to pay for this headquarters-based position is $123,000 - $146,000; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

 Applicants must be currently authorized to work in the United States on a full-time basis.